Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Cervical Ripening Clinical Trial

Official title:

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687436
• Other study ID #: mechanical cervical ripening
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2022
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.

Description:

This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error.

The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).

The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score >6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.

The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 40

• Singleton pregnancy

• Vertex presentation

• Bishop score <6

• Using a Foley catheter or cook balloon for cervical ripening

• High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders)

Exclusion Criteria:

• Being younger than 18 or over 40

• Communication problems (foreign national)

• Bishop score >6

• Being at active labor

• Multifetal pregnancy

• Non-vertex presentation

• Scarred uterus (cesarean or myomectomy)

• Fetal structural or chromosomal anomaly

• Non-reassuring fetal cardiotocography before cervical ripening

• Regional anesthesia during the first stage

Related Conditions & MeSH terms

• Cervical Ripening
• Pregnancy, High-Risk

Intervention

Device:
• mechanical cervical ripening
mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28. Erratum in: BJOG. 2011 Mar;118(4):521. McCleery, S [corrected to McChlery, S]. — View Citation

Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016 Nov;42(11):1489-1494. doi: 10.1111/jog.13086. Epub 2016 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bishop score	bishop score >6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)	at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
Primary	vaginal delivery rate	the difference in vaginal birth rate between groups	until the patient gives birth
Primary	vaginal delivery within 24 hours	the difference in vaginal delivery within 24 hours rate between groups	from the time of cervical ripening catheter insertion to the 24 hours